NCT00277368

Brief Summary

The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
719

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

January 13, 2006

Last Update Submit

April 26, 2010

Conditions

Epilepsy

Keywords

EpilepsyHeadacheSeizure

Outcome Measures

Primary Outcomes (1)

  • Rate of seizure-related headache among epilepsy patients and its classification

    At first visit (This study is cross-sectional)

Secondary Outcomes (2)

  • The pain intensity of seizure-related headache

    At 1st visit

  • The frequency of seizure-related headache

    At 1st visit

Study Arms (1)

001

Other: A structured questionnaire for seizure-related headache

Interventions

A structured questionnaire for seizure-related headacheOTHER

A structured questionnaire for seizure-related headache

001

Eligibility Criteria

Age13 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.

You may qualify if:

  • Patients with a recent diagnosis epilepsy
  • Able to describe their symptoms by themselves
  • Have had at least 2 episodes of seizures during the previous year
  • Have had at least 1 headache during the previous year

You may not qualify if:

  • Well-controlled epileptic patients taking anti-epileptic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EpilepsyHeadacheSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

July 1, 2005

Study Completion

March 1, 2006

Last Updated

April 27, 2010

Record last verified: 2010-04